[Federal Register Volume 84, Number 134 (Friday, July 12, 2019)]
[Notices]
[Page 33272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14823]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of an Exclusive Patent License: Autologus 
Therapy Using Bicistronic Chimeric Antigen Receptors Targeting CD19 and 
CD20

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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SUMMARY: The National Cancer Institute, an institute of the National 
Institutes of Health, Department of Health and Human Services, is 
contemplating the grant of an Exclusive Patent License to practice the 
inventions embodied in the Patents and Patent Applications listed in 
the Supplementary Information section of this notice to Kite Pharma, 
Inc. (``Kite'') located in Santa Monica, CA.

DATES: Only written comments and/or complete applications for a license 
which are received by the National Cancer Institute's Technology 
Transfer Center on or before July 29, 2019 will be considered.

ADDRESSES: Requests for copies of the patent application, inquiries, 
and comments relating to the contemplated an Exclusive Patent License 
should be directed to: David A. Lambertson, Ph.D., Senior Technology 
Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center 
Drive, RM 1E530 MSC 9702, Bethesda, MD 20892-9702 (for business mail), 
Rockville, MD 20850-9702 Telephone: (240) 276-5530; Facsimile: (240) 
276-5504 Email: [email protected].

SUPPLEMENTARY INFORMATION:

Intellectual Property

    United States Provisional Patent Application No. 62/732,263, filed 
17 September 2018 and entitled ``Bicistronic Chimeric Antigen Receptors 
Targeting CD19 and CD20 and Their Uses'' [HHS Reference No. E-205-2018-
0-US-01]; and U.S. and foreign patent applications claiming priority to 
the aforementioned application.
    The patent rights in these inventions have been assigned and/or 
exclusively licensed to the government of the United States of America.
    The prospective exclusive license territory may be worldwide and 
the field of use may be limited to the following:
    ``The development, production and commercialization of an anti-CD19 
anti-CD20 dual targeting chimeric antigen receptor (CAR)-based 
immunotherapy using autologous (meaning one individual is both the 
donor and the recipient) immune cells transfected with either a viral 
or non-viral vector, wherein the vector expresses a CAR having at 
least:
    (1) A dual antigen specificity;
    (2) the complementary determining region (CDR) sequences of the 
anti-CD19 antibody known as Hu19;
    (3) the complementary determining region (CDR) sequences of the 
anti-CD20 antibody known as 2.1.2; and
    (4) a T cell signaling domain;

for the treatment of B-cell derived human cancers.''
    This technology discloses the development of chimeric antigen 
receptors that recognize both the CD19 and CD20 cell surface proteins. 
CD19 and CD20 are expressed on the cell surface of several 
hematological malignancies, including Non-Hodgkins Lymphoma (NHL), 
acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia 
(CLL). Although the FDA has recently approved CAR-based therapies which 
target only CD19 (Yescarta, Kymriah), tumors are capable of undergoing 
tumor antigen escape (the downregulation of target antigen expression 
on tumor cells), which results in gradual resistance to ``single target 
therapies.'' As a result, patients receiving single target CAR 
therapies are susceptible to relapse. This has prompted investigators 
to pursue dual targeting CAR therapies to provide as a means of 
overcoming tumor antigen escape, thereby providing a more comprehensive 
therapeutic alternative. The development of a new therapeutic targeting 
both CD19 and CD20 will benefit public health by offering up an 
improved treatment for patients that would otherwise be subject to 
relapse due to tumor antigen escape.
    This notice is made in accordance with 35 U.S.C. 209 and 37 CFR 
part 404. The prospective exclusive license will be royalty bearing, 
and the prospective exclusive license may be granted unless within 
fifteen (15) days from the date of this published notice, the National 
Cancer Institute receives written evidence and argument that 
establishes that the grant of the license would not be consistent with 
the requirements of 35 U.S.C. 209 and 37 CFR part 404.
    In response to this Notice, the public may file comments or 
objections. Comments and objections, other than those in the form of a 
completed license application, will not be treated confidentially, and 
may be made publicly available.
    License applications submitted in response to this Notice will be 
presumed to contain business confidential information and any release 
of information in these license applications will be made only as 
required and upon a request under the Freedom of Information Act, 5 
U.S.C. 552.

    Dated: July 2, 2019.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer 
Institute.
[FR Doc. 2019-14823 Filed 7-11-19; 8:45 am]
BILLING CODE 4140-01-P